MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE; INSULIN INFUSION PUMP

Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.
Event or Problem Description
On (b)(6) 2017, the reporter contacted animas alleging a button/keypad (tactile changes/unresponsive) issue.It was reported that the up arrow, down arrow, and ok keypad buttons were under responsive to user presses.There is no indication that the product issue caused or contributed to an adverse event.This complaint is being reported because the issue has the ability to result in inadvertent or incorrect insulin delivery or the inability to use the pump.
Additional Manufacturer Narrative
Follow-up #1: date of submission 09/01/2017 - device evaluation: the pump has been returned and evaluated by product analysis on 08/03/2017 with the following findings: the keypad was found to be intact; no damage was observed.During investigation, the keypad buttons were found to respond appropriately to button presses.The keypad cover was removed and no contamination was found under the button contacts; no button contact defects were observed.The complaint of a keypad button response issue was not duplicated during investigation.Unrelated to the complaint, investigation revealed evidence of moisture on the keypad flex connector.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 6704892
• Report Number: 2531779-2017-14409
• Device Sequence Number: 877965
• Product Code: OYC
• UDI-Device Identifier: 10840406100303
• UDI-Public: 0110840406100303
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P130007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 62